| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | MINIMED 530G INSULIN PUMP |
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| Generic Name | Automated insulin dosing , threshold suspend |
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| Applicant | Medtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P120010 |
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| Supplement Number | S039 |
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| Date Received | 10/27/2014 |
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| Decision Date | 11/26/2014 |
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| Product Code |
OZO |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT01112696
|
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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